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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLLISTER INCORPORATED NEW IMAGE CLOSED POUCH WITH QUIET WEAR POUCH MATERIAL OSTOMY BARRIER

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HOLLISTER INCORPORATED NEW IMAGE CLOSED POUCH WITH QUIET WEAR POUCH MATERIAL OSTOMY BARRIER Back to Search Results
Model Number 18323
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Unspecified Infection (1930); Ulcer (2274); Reaction (2414)
Event Date 03/29/2016
Event Type  Injury  
Manufacturer Narrative
Biocompatibility testing has been performed in accordance with is0 10993 and materials were found to be non-sensitizers.
 
Event Description
It was reported by the user that for the last 1. 5 years she has developed chronic ulcers under her barrier, pouch and paste. During this same time she has also developed reactions to the elastic band in her underwear, ekg electrodes, paper tape, (b)(6) and other manufacturer's ostomy products. She develops reactions under the skin where the pouch touches her. She has tried placing materials between the pouch and her skin but she develops reactions to those as well. She has had 90 skin patch tests including hollister products and they come up with a positive reaction. Her skin peels off when she develops these reactions and she often develops infections requiring antibiotics and steroid creams.
 
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Brand NameNEW IMAGE CLOSED POUCH WITH QUIET WEAR POUCH MATERIAL
Type of DeviceOSTOMY BARRIER
Manufacturer (Section D)
HOLLISTER INCORPORATED
2000 hollister dr
libertyville IL 60048
Manufacturer (Section G)
HOLLISTER INCORPORATED
366 draft avenue
stuarts draft VA 24477 9998
Manufacturer Contact
anne riba
2000 hollister dr
libertyville, IL 60048
8476805625
MDR Report Key5608888
MDR Text Key43666293
Report Number1119193-2016-00006
Device Sequence Number1
Product Code EXB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Patient
Type of Report Initial
Report Date 03/29/2016,04/26/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number18323
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location Home
Date Report to Manufacturer03/29/2016
Date Manufacturer Received03/29/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/26/2016 Patient Sequence Number: 1
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